MAUDE Adverse Event Report: ZIMMER BIOMET, INC. BIAXIAL ELBOW SYSTEM CONNECTING SEGMENT WITH CLIP; PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED

Catalog Number	CP562351
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported by the pmi group that the patient underwent a left elbow arthroplasty approximately eight (8) years and eight (8) months ago to receive a pmi device.Subsequently, the patient is being considered for another pmi device on an unknown date for an unknown reason.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# unk humeral bearing; lot# unknown, item# unk ulnar bearing; lot# unknown.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d1; d2; d4; d10; g1; g3; g4; g6; h1; h2; h3; h4; h6; h10.D10: item# cp562345; lot# 977180.Item# cp562344; lot# 976430.Item# cp562342; lot# 975970.Item# cp562343; lot# 995110.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Medical records were not provided.Review of the device history records identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is not confirmed.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: BIAXIAL ELBOW SYSTEM CONNECTING SEGMENT WITH CLIP
• Common Device Name: PROSTHESIS, ELBOW, CONSTRAINED, CEMENTED
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21255257
• Report Number: 0001825034-2025-00211
• Device Sequence Number: 8967595
• Product Code: JDC
• UDI-Device Identifier: 00880304820913
• UDI-Public: (01)00880304820913(17)260505(10)087160
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K980428
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/05/2026
• Device Catalogue Number: CP562351
• Device Lot Number: 087160
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2025
• Supplement Date Received by Manufacturer: 06/19/2025
• Initial Report FDA Received Date: 01/28/2025
• Supplement Report FDA Received Date: 06/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2016
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown